然而,如果数据不充分,资格预审程序时间就会大大延长,因为制造厂商必须提交必要的评估数据。
If data are insufficient, however, the process can take considerably longer since the manufacturer must submit the necessary data for reassessment.
如果提交的数据完整并可证明产品达到规定的各项标准,世卫组织的药品资格预审程序所需时间可仅为三个月。
The WHO prequalification of medicines process can take as little as three months, provided the data presented are complete and demonstrate that the product meets all required standards.
这些程序使世卫组织资格预审过程成为迄今所有类似质量保证规划中最透明的。
These procedures make the WHO prequalification process the most transparent of all similar quality assurance programmes to date.
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